avacopan

FDA Drug Profile — TAVNEOS

Drug Details

Generic Name
avacopan
Brand Names
TAVNEOS
Application Number
NDA214487
Sponsor
ChemoCentryx, Inc.
NDC Codes
1
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
AVACOPAN

Indications and Usage

1 INDICATIONS AND USAGE TAVNEOS is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use. TAVNEOS is a complement 5a receptor (C5aR) antagonist indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use. ( 1 )